NA 170003-27Recalls & reported problems
Nucletron B.V. · Oncentra External Beam/Oncentra Brachy v4.5.3 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
4 other recalls cover devices cleared under the same FDA submission (K121448, K132816); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Dec 5, 2022Open, Classified
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Z-0719-2023 · Root cause: Software design · Recall details · FDA record ↗
- Oct 13, 2021Open, Classified
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Z-0182-2022 · Root cause: Software design · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121448, K132816. One submission often covers many models, so check the product and lot details in each record.
- Z-0050-2018 · Aug 10, 2017 · TerminatedOncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiati
- Z-0987-2017 · Dec 23, 2016 · TerminatedOncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the
- Z-0604-2016 · Dec 18, 2015 · TerminatedOncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radia
- Z-1712-2015 · May 21, 2015 · TerminatedOncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
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- RayStation 8.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 10.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls1 report
- RayStation 8.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls0 reports
- RayStation 10.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 8.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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